A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma

NCT01989325

Last updated date
Study Location
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Multiple Myeloma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Confirmed multiple myeloma with measurable disease.

- Disease refractory to last myeloma regimen.

- Patients must have received at least 2 prior treatment regimens, including bortezomib and an IMiD (e.g., lenalidomide, thalidomide, pomalidomide). Induction therapy and stem cell transplant ± maintenance are to be considered as a single regimen.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study treatment.

- Adequate hematology, liver and renal function laboratory values within 14 days prior to first dose of study treatment.

- Additional criteria exist.

Key

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior treatment with carfilzomib, filanesib, or any other KSP inhibitor.


- Past or current plasma cell leukemia.


- Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).


- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and
skin changes).


- Ongoing Grade 3 or Grade 4 peripheral neuropathy, or Grade 2 peripheral neuropathy
with pain despite appropriate interventions, within 28 days prior to first dose of
study treatment.


- Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to
first dose of study treatment.


- Concomitant malignancies or previous malignancies (other than multiple myeloma) with
less than a 2-year disease-free interval at the time of first dose of study treatment.
Patients with adequately resected basal or squamous cell carcinoma of the skin,
carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible
irrespective of the time of diagnosis.


- Known pulmonary hypertension of any severity.


- Concurrent cardiac disease that, in the judgment of the Investigator, would make the
patient inappropriate for study participation.


- Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B
and/or hepatitis C.


- Acute active infection requiring treatment.


- Additional criteria exist.

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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Multiple MyelomaA Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
NCT01989325
  1. Hot Springs, Arkansas
  2. Los Angeles, California
  3. Santa Rosa, California
  4. Fort Myers, Florida
  5. Chicago, Illinois
  6. Marrero, Louisiana
  7. Boston, Massachusetts
  8. Detroit, Michigan
  9. Hattiesburg, Mississippi
  10. Omaha, Nebraska
  11. New York, New York
  12. Charlotte, North Carolina
  13. Cincinnati, Ohio
  14. Cleveland, Ohio
  15. Columbus, Ohio
  16. Portland, Oregon
  17. Watertown, South Dakota
  18. Nashville, Tennessee
  19. Dallas, Texas
  20. Fairfax, Virginia
  21. Morgantown, West Virginia
  22. Milwaukee, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
Official Title  ICMJE Not Provided
Brief Summary This is a Phase 2 study during which patients with advanced multiple myeloma will receive either carfilzomib alone (single-agent) or carfilzomib in combination with investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of both single-agent carfilzomib and carfilzomib + filanesib in treating myeloma. Patients will be allowed to crossover from single-agent carfilzomib to carfilzomib + filanesib if disease progression occurs. Approximately 75 patients from the US will be enrolled in this study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Multiple Myeloma
Intervention  ICMJE
  • Drug: Carfilzomib, proteasome inhibitor; intravenous
    multiple dose, single schedule
  • Drug: Filanesib, KSP(Eg5) inhibitor; intravenous
    multiple dose, single schedule
  • Drug: Dexamethasone, steroid; oral or intravenous
    as indicated, per the carfilzomib prescribing information
  • Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
    standard of care
Study Arms  ICMJE
  • Experimental: Carfilzomib + Filanesib

    Single agent + Carfilzomib arm.

    Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.

    Filgrastim to be administered per the approved product prescribing information and institutional guidelines.

    Interventions:
    • Drug: Carfilzomib, proteasome inhibitor; intravenous
    • Drug: Filanesib, KSP(Eg5) inhibitor; intravenous
    • Drug: Dexamethasone, steroid; oral or intravenous
    • Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
  • Experimental: Carfilzomib

    Single agent arm.

    Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.

    Interventions:
    • Drug: Carfilzomib, proteasome inhibitor; intravenous
    • Drug: Dexamethasone, steroid; oral or intravenous
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2016)
77
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2013)
75
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Confirmed multiple myeloma with measurable disease.
  • Disease refractory to last myeloma regimen.
  • Patients must have received at least 2 prior treatment regimens, including bortezomib and an IMiD (e.g., lenalidomide, thalidomide, pomalidomide). Induction therapy and stem cell transplant ± maintenance are to be considered as a single regimen.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study treatment.
  • Adequate hematology, liver and renal function laboratory values within 14 days prior to first dose of study treatment.
  • Additional criteria exist.

Key Exclusion Criteria:

  • Prior treatment with carfilzomib, filanesib, or any other KSP inhibitor.
  • Past or current plasma cell leukemia.
  • Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).
  • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
  • Ongoing Grade 3 or Grade 4 peripheral neuropathy, or Grade 2 peripheral neuropathy with pain despite appropriate interventions, within 28 days prior to first dose of study treatment.
  • Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study treatment.
  • Concomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of first dose of study treatment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis.
  • Known pulmonary hypertension of any severity.
  • Concurrent cardiac disease that, in the judgment of the Investigator, would make the patient inappropriate for study participation.
  • Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C.
  • Acute active infection requiring treatment.
  • Additional criteria exist.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01989325
Other Study ID Numbers  ICMJE ARRAY-520-216
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Clinical Trial Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP